Tolerance of Cereals for Atopic Children

Allergy Clinical Trial

Official title:

Assessment of Tolerance of Cereals in Infants With Atopic Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01029184
• Other study ID #: 07.47.INF
• Status: Terminated
• Phase: N/A
• First received: December 8, 2009
• Last updated: June 26, 2012
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

In this study, non allergenic cereals will be tested in infants with atopic symptoms. The test will be performed in a hospital.

Description:

In the majority of food allergy cases, an exclusion diet results in regression of clinical symptoms but this diet may not be nutritionally complete. To feed a baby who has a food allergy, we want a food with low allergenic ingredients.

For this reason, a complete cereal has been specially developed and formulated for the weaning period of infants and young children suffering from milk, soy or wheat protein allergy or hypersensitivity due to celiac disease.

It allows a smooth transition into and through the weaning period. The ingredients of this product are all from vegetable sources and it is therefore suitable for a vegetarian diet. It has been commercialised for many years and has proved to be completely safe, however so far no study has been specifically designed and powered to assess tolerance of this product in infants with atopic symptoms.

In this study we are testing the tolerance (symptoms stability) of non allergenic cereals during an open allergenic test in infants with atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test. We are also testing the same product containing an additional ingredient with a potential effect in allergy management.

Such complete cereals is a very good option for allergic children in comparison to an exclusion diet that may not be nutritionally complete.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 4 Years

Eligibility

Inclusion Criteria:

• Infant aged from 4 to 40 months at the time of enrolment

• With atopic symptoms and/or positive Skin Prick Test (SPT) or positive specific RAST-IgE or positive Patch Test

• Infants who received a specific elimination oligoallergenic diet from the study site for at least 5 days before the day of enrolment

• Having obtained his/her signed legal representative's informed consent

Exclusion Criteria:

• Infant on systemic drugs (e.g. antihistamines) according to half-life at time of enrolment

• Congenital illness or malformation that may affect normal growth (especially immunodeficiency)

• Infant whose parents / caregivers cannot be expected to comply with treatment.

• Infant currently participating in another interventional clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy

Intervention

Other:
• commercialized complete cereals
complete cereals suitable for the weaning period
• commercialized complete cereals with additional ingredient
complete cereals suitable for weaning period

Locations

Country	Name	City	State
Germany	Kinderarzt-Allergologie-Sportmedizin Fachklinik Gaißach	Gaißach bei Bad Tölz

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of atopic symptoms and clinical examination for presence or absence of some objective and subjective symptoms with evaluation of severity (SCORAD) if necessary		48 hours	Yes
Secondary	Morbidity will be assessed by the frequency of adverse events		48 hours	Yes